Senior Quality Engineer, Non-Active Medical Devices

Fresenius Medical Care; Reynosa; On-site; MXN 600,000 - 900,000; Full time

Benefits offered by this job

Career development

Diverse team environment

Global medical devices company

Job summary

Fresenius Medical Care Reynosa plant seeks a Senior Quality Engineer for Non-Active Medical Devices. You will act as SME for manufacturing quality, leading CAPA investigations, risk assessments, and design transfers to ensure product reliability.

The role requires 3–5 years in regulated medical devices, strong QA tools knowledge, and leadership across cross-functional teams. ISO 13485 and FDA Part 820 experience are essential.

Qualifications

• Bachelor’s degree in Electronic, Mechanical, Industrial Engineering or related field.
• 3–5 years in Quality/Manufacturing Engineering in regulated medical devices.
• Experience leading complex quality investigations and CAPA resolution.
• Experience with design transfer from R&D to manufacturing.
• Experience with PFMEA, risk assessments and data analysis.
• Knowledge of SPC, MSA, DOE, ANOVA and probability analysis.
• Experience with process validation and TMV.
• Lean Manufacturing and Six Sigma tools familiar.
• Strong quality system knowledge: ISO 13485, FDA 21 CFR Part 820, MDSAP.
• Supplier quality management and CAPA systems exposure.
• Advanced English required; US visa may be required.

Responsibilities

• Act as SME in Manufacturing Quality Engineering for NAMD.
• Analyze quality trends, process capability, and defect patterns.
• Lead quality risk assessments and improvement opportunities.
• Provide technical leadership to cross-functional teams.
• Lead root cause investigations involving CAPAs and defects.
• Drive structured problem solving (8D, DMAIC, statistics).
• Evaluate CAPA effectiveness through trend analysis.
• Support design transfer activities for manufacturing readiness.
• Participate in design reviews and risk assessments.
• Review technical documents: drawings, specs, test methods.
• Lead or support validation activities: TMV, equipment qualification, MSA.
• Ensure documentation aligns with regulatory requirements.
• Identify systemic quality issues and drive improvements.
• Support PFMEA updates and risk management activities.
• Collaborate with multiple departments and sites.

Skills

Quality engineering

CAPA leadership

Root cause analysis

Design transfer

PFMEA

Process capability

SPC

DOE

Minitab

Lean Six Sigma

ISO 13485 knowledge

FDA 21 CFR Part 820

MDSAP

Supplier quality

Quality audits

Education

Bachelor's Degree in Electronic/Mechanical/Industrial Engineering

Tools

Minitab

ERP/MES

Job description

Fresenius Medical Care Reynosa plant seeks a Senior Quality Engineer for Non-Active Medical Devices. You will act as SME for manufacturing quality, leading CAPA investigations, risk assessments, and design transfers to ensure product reliability.

The role requires 3–5 years in regulated medical devices, strong QA tools knowledge, and leadership across cross-functional teams. ISO 13485 and FDA Part 820 experience are essential.